]>
IRCT20120716010297N9 IRCT 2020-08-17 Esfahan University of Medical Sciences The role of propranolol with L-carnitine in the prophylactic treatment of cyclic vomiting syndrome Comparison of the effect of propranolol alone and propranolol with L-carnitine in the prophylactic treatment of cyclic vomiting syndrome in children 2020-08-22 anticipated 104 Complete https://irct.ir/trial/49926 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, eligible patients will be simple randomly selected. Then they will be divided into two groups of 52 using the random block method with 2 blocks. So that the first two cases are separated and assigned to group one, the second two cases are separated and assigned to group two, and this will be continued two by two in the same way till the ending of samples, Blinding description: Due to the different dosage of the drugs and the combination of the two drugs in one of the two groups, it is not possible for the researcher to be blind and the child's parents will be aware. But a statistician of the two groups will not know. 3 Cyclic vomiting syndrome. Intervention 1: Intervention group 1: Patients receive propranolol tablets (Poursina Pharmaceutical Co.) at a dose of 1 mg/kg daily with L-carnitine tablets (Poursina Pharmaceutical Co.) at a dose of 50-100 mg/kg with a maximum dose of 2 g daily for three months. Intervention 2: Intervention group 2: Patients receive only propranolol (Poursina Pharmaceutical Co.) at a dose of 1 mg/kg daily for three months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Fatemeh Famouri
Unit 4, Parisa apartment, Alley 5, Mehrabad Street, Isfahan
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3668 0048 fat.famoori@gmail.com Esfahan University of Medical Sciences scientific Fatemeh Famouri
Unit 4, Parisa apartment, Alley 5, Mehrabad Street, Isfahan.
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3668 0048 fat.famoori@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) cyclic vomiting syndrome with more than two attacks in a month No seizures No metabolic diseases No gastrointestinal diseases 3 years 18 years Both G43.A0 Cyclical vomiting Treatment - Drugs Treatment - Drugs Intervention group 1: Patients receive propranolol tablets (Poursina Pharmaceutical Co.) at a dose of 1 mg/kg daily with L-carnitine tablets (Poursina Pharmaceutical Co.) at a dose of 50-100 mg/kg with a maximum dose of 2 g daily for three months. Intervention group 2: Patients receive only propranolol (Poursina Pharmaceutical Co.) at a dose of 1 mg/kg daily for three months. Incidence of vomiting attacks. Timepoint: Before and during 6 months after the start of the intervention. Method of measurement: Observation. Severity of vomiting attacks. Timepoint: Before and during 6 months after the start of the intervention. Method of measurement: Visual scale(Score 1 lowest severity and score 10 highest severity of vomiting attacks). Isfahan University of Medical Sciences Approved 2019-12-22 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)